Appendix E: Clinical Study Summary - Johnson & Johnson Codman VPV System Mode D'emploi

2. Press the "30" key to set the next adjustment cycle for an inverted valve, or press "40" to exit. When you
press "30," the display changes to:
3. To confirm that the next adjustment cycle is for an inverted valve, press "80"; or press "40" to cancel and
exit. When you press "80," the display changes to:
Proceed as usual, following the steps in Valve Adjustment: Implanted Valve Mode. At the end of the adjustment
cycle, the program unit returns to the normal adjustment cycle.

Appendix E: Clinical Study Summary

In a clinical study consisting of 172 subjects, 159 subjects had an x-ray taken with a blinded core lab consensus
reading. In these 159 subjects, 103 (65%) of the subjects received an "Adjustment Complete" message and
56 (35%) of the subjects received a "Repeat Adjustment" message. Of the "Adjustment Complete" patients,
55% received an "Adjustment Complete" message after the first attempt at reprogramming and 99% received
the "Adjustment Complete" message within the 5 attempts established in the study design.
CODFR10065zz10svn.indd 11 CODFR10065zz10svn.indd 11
ADJUST INVERTED
VALVE?
PLEASE CONFIRM
80 = YES 40 = NO
IMPLANTED VALVE
INVERTED VALVE
PLEASE SELECT
PRESSURE
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